Kornimate/medical-research-clean huggingface dataset:
a dose escalation and confirmation study of pt-112 in advanced solid tumors in combination with avelumab

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Summary: this is a phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of pt-112 in combination with the anti-pd-l1 antibody, avelumab, in selected advanced solid tumors. the study is to be conducted in two parts: the dose escalation phase of pt-112 within the combination and the dose confirmation phase in patients with non-small cell lung cancer who will be treated at the rp2d.

this is a phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of pt-112 in combination with the anti-pd-l1 antibody, avelumab, in selected advanced solid tumors. the study is to be conducted in two parts: the dose escalation phase and the dose confirmation phase. enrollment for dose escalation and dose confirmation is complete.

Eligibility criteria:
key inclusion criteria: 1. histologically or cytologically confirmed metastatic or locally advanced, squamous or non-squamous nsclc (nsclc). patients must have received no more than four prior lines of therapy, including a pd-1 / pd-l1-containing therapy and a platinum containing regimen. patients must have received no more than one taxane containing regimen and no more than one investigational agent; 2. must provide study-related tumor specimens; 3. ecog(ps) 0-1; 4. estimated life expectancy \> 3 months; 5. adequate bone marrow (bm), renal, hepatic and metabolic function. key exclusion criteria: 1. concurrent cancer treatment with cytoreductive therapy, radiotherapy, cytokine therapy, cytotoxic agents, targeted small molecule therapy or any investigational anticancer small molecule drugs within 2 weeks prior to the start of study treatment (except 5 weeks from last dose of nitrosourea compound) or treatment with monoclonal antibodies within 4 weeks prior to the start of study treatment; 2. known symptomatic central nervous system (cns) metastases requiring steroids. 3. diagnosis of any other malignancy within 2 years prior to enrollment; 4. vaccination within 4 weeks of the first dose of study treatment is prohibited except for administration of inactivated vaccines; 5. current use of immunosuppressive medication at study entry; 6. active or prior autoimmune disease that might deteriorate with receiving an immunostimulatory agent; 7. acute or chronic infections requiring systemic therapy; 8. known history of autoimmune colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis; 9. known intolerance to checkpoint inhibitor therapy, defined by the occurrence of an ae leading to drug discontinuation; 10. participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.

Keywords: advanced solid tumors nsclc non-small cell lung cancer
the role of probiotics in preventing recurrent urinary tract infections in pregnant women

Conditions: Urinary Tract Infections

Summary: urinary tract infections (utis) are a significant public health problem affecting more than 150 million people worldwide and causing a significant economic impact of approximately us$ 6 billion annually. it is one of the most common infectious diseases after upper respiratory tract infections. more than 50% of women and at least 12% of men will be affected by urinary tract infections in their lifetime. the probiotic supplement was delivered as easy-to-swallow capsules specifically prepared to maintain the viability and stability of the lactobacillus rhamnosus gg strain throughout the research period. participants were told to take the probiotic supplement with water to maximise absorption and efficiency, ideally after meals.


Eligibility criteria:
inclusion criteria: * pregnant women aged 18-40 year * history of recurrent urinary tract infections (two or more episodes in the past year). * singleton pregnancy. exclusion criteria: * multiple gestations. * history of preterm labor. * chronic medical conditions (e.g., diabetes mellitus, immunodeficiency disorders). * use of antibiotics or probiotics within the past month.
booster study of combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults

Conditions: Diphtheria; Pertussis; Tetanus

Summary: the aim of the study is to assess the safety and immunogenicity of glaxosmithkline biologicals' (formerly known as smithkline beecham biologicals) combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18 onwards, in australia.


Eligibility criteria:
inclusion criteria: * at least 18 years of age at the time of the vaccination * written informed consent has been obtained exclusion criteria: * evidence of confirmed pertussis disease within the previous 5 years * history of diphtheria or tetanus vaccination within the past 5 years females must not be pregnant or lactating they must either surgically sterilized or one year post-menopausal or if they are of childbearing potential, they must be abstinent or have used adequate contraceptive precautions (or one month prior to the booster vaccination, and must agree to continue such precautions for 2 months after completion of the vaccination. * history of diphtheria or tetanus disease * history of allergic disease likely to be stimulated by the vaccination * major congenital defects or serious chronic illness * history of progressive neurological disease * immunosuppressive therapy * any suspected or confirmed immune disorder * immunoglobulin therapy or administration of any blood products within the previous three months or during the study period * acute febrile illness (\>37.5°c, axillary or oral temperature) at the time of planned vaccination * administration of an investigational or non registered drug or vaccine within 30 days prior to the start of the present trial * simultaneous administration of a vaccine not foreseen by the study protocol, within 30 days prior to the start of the present trial * any severe or serious adverse experience having occurred after previous administration of dtp vaccine i.e: * an immediate anaphylactic or unacceptable reaction to the investigator's opinion, to a previous dose of diphtheria tetanus pertussis whole-cell vaccine, i.e. : * encephalopathy * fever \> 40.5°c (105°f), rectal temperature, occurring after vaccination with diphtheria tetanus pertussis whole-cell vaccine and not due to another identifiable cause. * collapse or shock-like state * persistent, inconsolable crying lasting \> 3 hours * seizures with or without fever * systemic allergic or neurologic reactions following a previous dose of tetanus and diphtheria toxoids vaccine * exclusion from long term follow-up of antibody persistence : evidence of confirmed pertussis, diphtheria or tetanus disease or vaccination against these diseases since previous study visit

Keywords: booster vaccination
cost-effectiveness in bladder cancer

Conditions: Bladder Cancer

Summary: this randomized clinical multicentre trial aims to evaluate the efficacy of microsatellite analysis on voided urine to detect tumour recurrences in the follow-up of patients with superficial urothelialcell carcinoma (ucc). further, this study aims to identify subgroups of patients with a low risk of tumour recurrence using clinico-pathologic tumour characteristics in combination with a genetic marker (fgfr3 gene), such that the frequency of follow-up contact can be reduced. the overall objective is to reduce the frequency of cystoscopy during follow-up in patients with superficial ucc, leading to an improvement in quality of life at equal or lower costs. this study evaluates the cost-effectiveness of follow-up in bladder cancer.

the randomized clinical study consists of two intervention arms. the control arm consists of a conventional follow-up based on regular monitoring for urinary bladder ucc recurrences by cystoscopy. in the test arm a proportion of the cystoscopies is replaced by microsatellite analysis on voided urine. both arms will be stratified for clinical and pathological tumour parameters as well as for the mutation status of the prognostic fgfr3 gene mutation.

Eligibility criteria:
inclusion criteria: * all patients with resectable pt1 or pta, grade g1-g2 transitional cell carcinoma of the bladder which is biopsy proven exclusion criteria: * patients who present or presented with a transitional cell carcinoma of the bladder, stage pt2 or more invasive, or carcinoma in situ (cis) and/or g3 diagnosed in history

Keywords: superficial urothelial cell carcinoma urinary analysis loss of heterozygosity fgfr3 mutation follow-up
usefulness of shirodhara for insomnia

Conditions: Insomnia

Summary: this pilot study will attempt to test the effects of this non-invasive procedure on a small sample of insomnia patients and also determine the feasibility of recruiting and retaining participants during the trial for such treatments in the united states.

a prospective case series design will be adopted. due to the small sample size and the preliminary nature of the study, a single case study or case series are classified under observational descriptive studies. the investigators will seek local institutional review board (irb) approval. ten volunteers who respond to the recruitment efforts will be enrolled into the study. successful enrollment is based on strict inclusion and exclusion criteria. brahmi oil (sesame oil processed with bacopa monieri and other herbs) will be used to perform shirodhara. each participant will be treated for 40 minutes for five consecutive days. outcome measures data will be collected at baseline, third day and fifth day and a week after the treatment is over. additionally, demographic data will be collected at baseline as well. participants will be asked to record any adverse events or side effects they observe during the study period.

Eligibility criteria:
inclusion criteria: * age 18-75 of either sex * duration of insomnia at least one year * willing to sign an informed consent * a score of minimum 14 on the insomnia severity index exclusion criteria: * comorbidities such as depression or any other psychological conditions that require medications * currently on prescription medication for insomnia * serious medical conditions such as uncontrolled hypertension, uncontrolled diabetes, or any other acute condition that disturbs sleep and requires waking up in the middle of the night * participants unwilling to comply with the protocol * anyone who is in litigation or receiving disability, workers' compensation benefits

Keywords: insomnia ayurveda shirodhara quality of life
a trial of ly3056480 in patients with snlh

Conditions: Sensorineural Hearing Loss

Summary: a phase 2 trial with ly3056480 in patients with stable snhl

vesta is a double blinded, randomized, placebo controlled, multi center efficacy phase 2 study comparing three dosing regimens of 250 µg ly3056480. adult volunteers with stable mild to moderately-severe snhl will be recruited through adult otolaryngology - head \& neck surgery services in the us. four injections of 250µg ly3056480 or placebo administered trans-tympanically into one ear (worse hearing ear).

Eligibility criteria:
inclusion criteria: 1. male or female between 18 - 65 years of age; 2. minimum of six months of documented stable hearing loss (+/- 5db); 3. a documented stable word recognition test (stable for \~ 6 months +/- 6%/3 words) exclusion criteria: 1. presenting with a primary complaint of tinnitus 2. any conductive hearing loss of greater than 15 db at a single frequency or greater than 10 db at two or more contiguous octave frequencies in the study ear 3. history of suspected or diagnosed genetic cause of hearing loss; 4. partial deafness as defined as hearing loss in any frequency (up to 8 khz) greater than 80db 5. suspected or known diagnosis of the following inner ear pathology, congenital hearing loss, fluctuating hearing loss, ménière's disease, or secondary endolymphatic hydrops, perilymph fistula, cochlear barotrauma, autoimmune hearing loss, radiation-induced hearing loss, retro-cochlear lesion, ototoxicity 6. evidence of acute or chronic otitis media or otitis externa on examination; or a history of middle ear pathology and/or surgery (except for ear tubes as a child) 7. any therapy known as ototoxic 8. participant in a previous trial of ly3056480
left atrial appendage closure with watchman flx device in recurrent gastrointestinal bleeding: the gi-flx registry

Conditions: Atrial Fibrillation; GI Bleeding

Summary: the gi-flx registry is intended to create a registry of patients with a history of atrial fibrillation (af) and gastrointestinal (gi) bleed who will receive left atrial appendage closure (laac) with watchman flx device and compare to patients with af and gi bleed who do not have laac. the gi-flx registry will be a multi-center, non-randomized registry. approximately 250 prospective patients will be enrolled at all 4 sites. historical cohort of 250 patients after propensity score matching with watchman-flx arm will be included in the final analysis.

a large gap in the literature exists as no prior study has evaluated the outcomes of those with prior gi bleeding undergoing laac. furthermore, patients with prior gi bleed may be on no or minimal antithrombotic therapy prior to laac and subsequently require escalation of antithrombotic therapy following laac. long-term outcomes including bleeding events will be most relevant and informative to this potentially high-risk subgroup. therefore, this is an attempt to create a prospective registry describing outcomes of patients with af and prior gi bleed undergoing laac to provide insight into safety and efficacy and will also compare to a historical cohort of patients with af and gi bleed without laac.

Eligibility criteria:
inclusion criteria: * all male and female patients who are \> 18 years of age * have atrial fibrillation * have chads2vasc \> 2 * have history of gi bleeding or hospital admission that required blood transfusion or emergency room visit requiring stopping of oac or outpatient 2 gm of hgb drop from baseline, with or without evidence of upper or lower gi bleeding and requiring endoscopic procedure with holding of oac. * ability to understand study procedures and to comply with them for the entire length of the study. exclusion criteria: * inability or unwillingness of individual to give written informed consent. * other indications for oac like deep vein thrombosis (dvt) or pulmonary embolism (pe) or mechanical heart valve. * patient who is pregnant will be excluded (pregnancy will be excluded by checking urine beta-hcg). * patient not following up with our practice / clinic after the procedure
intravenous (iv) nitroglycerin for versions in multiparous women

Conditions: Breech Presentation; Pregnancy Complication

Summary: breech presentations (where a baby presents with feet or bottom down) have an increased risk of perinatal and neonatal complications, and are usually delivered by cesarean section. as an alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the baby so that it is head down: this manoeuvre is called an external cephalic version (ecv). drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ecv success rates. nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested as an agent to help ecv. there is some suggestion that nitroglycerin may be more helpful in women who have not previously been pregnant (nulliparous women) than in women who have been pregnant more than once (multiparous women), and so we have planned two trials. this study is designed to answer the following questions for multiparous women: will administration of iv nitroglycerin for uterine relaxation improve ecv success rates? will an increase in ecv success result in a decreased cesarean section rate?


Eligibility criteria:
inclusion criteria: * any non-cephalic presentation * singleton pregnancy * \>/= 37 weeks gestational age * normal amniotic fluid volume * reassuring fetal heart rate exclusion criteria: * labor * ruptured membranes * history of third trimester bleeding * any pre-existing uterine scar * pregnancy induced hypertension and gestational diabetes * oligohydramnios and polyhydramnios * intrauterine growth restriction or macrosomia * hypotension or any serious medical illness * inability to comprehend consent form
pilot testing a novel non-invasive lactate sensor

Conditions: Hyperlactatemia

Summary: to test the efficacy and accuracy of a novel non-invasive lactate sensor in humans undergoing strenuous leg exercise.

the study investigators have designed a novel non-invasive lactate sensor (lactisense) lactisense is a planar, flexible, passive, chip-less resonator that can be taped to the skin in order to measure lactate levels in the body. it sends a signal to a nearby reader, which can be translated into a concentration value. it has so far been tested in the lab with good accuracy, but has not been tested on humans. the sensors are designed to use very low energy microwaves that can detect alterations in interstitial and muscle metabolites. in this study the investigators will test the sensor by having participants perform strenuous exercise (lifting weights) with lactisense sensors attached to their skin on the top of the thigh and upper arm to evaluate lactate levels at the site of production and systemic levels respectively. the exercise will be performed using a well-established protocol to elevate lactate levels using a leg-press weights machine. the investigators will use a commercial capillary blood lactate meter (via finger prick) to verify whether lactate levels are actually changing in the body, and use lactisense to try to measure these changes and compare to the values obtained using the commercial capillary blood lactate meter.

Eligibility criteria:
inclusion criteria: healthy and physically active volunteers exclusion criteria: existing health conditions e.g blood pressure \> 150/95, joint injury that would contraindicate exercise. individuals who answer "yes" to any of the health condition questions on the par-q questionnaire will also be excluded. as ketones might interfere with the sensor signal, we will exclude anyone with metabolic conditions or following a ketogenic diet.
linac fractionated radiosurgical thalamotomie in tremors (fracthal)

Conditions: Essential Tremor; Parkinsonian Disorders

Summary: radiosurgical thalamotomy on gammaknife has been shown to be effective in the management of tremors. however, several teams describe a significant risk of severe neurological complications. in addition, fitting the invasive frame and the need to travel to gammknife centers often limit access to treatment in this population of elderly patients. linear accelerators have greatly improved their precision, now reaching that of gammaknife. a possible alternative is therefore to treat patients on linear accelerators, without an invasive frame. the objective of the fracthal study is to assess the feasibility and safety of treatment of essential and / or parkinsonian tremor by fractional radiosurgical thalamotomy on a linear accelerator. the main hypothesis of the fracthal study is based on the fact that dividing the dose into 3 sessions will both protect healthy tissue around the target while maintaining therapeutic efficacy on the treatment target.


Eligibility criteria:
inclusion criteria: * patient with disabling essential tremor, dystonic and / or parkinsonian in one or more limbs superiors ; * patient contraindicated or refusing deep brain stimulation ; * patient ≥ 18 years old, * women of childbearing potential must take effective contraception ; * signature of informed consent ; p- atients who benefited from contralateral thalami c stimulation can be included in the study exclusion criteria: * brain irradiation history ; * contraindication or inability to perform injected mri ; * life expectancy \<12 months ; * claustrophobic patient who cannot stand the radiotherapy mask ; * abnormal anatomy of the thalamic region ; * treatment with a trial drug within 30 days of entering the study ; * presence of medical, psychological, social or geographic factors likely to modify the patient's compliance with the protocol under study or the monitoring or signing of the consent
the effect of oral alpha-cyclodextrin on fecal fat excretion

Conditions: Obesity; Cardiovascular Disease

Summary: saturated fat leading to elevated low density lipoprotein (ldl) cholesterol is considered a cardiovascular risk factor. the properties associated with α- cyclodextrin, allow it to selectively reduce saturated fat and calories which will have a medically beneficial effect on ldl cholesterol and obesity. the purpose of the research is to evaluate this effect of α- cyclodextrin. it is hypothesized that alpha cyclodextrin supplementation will increase fecal fat on a high saturated fat diet compared to the same diet supplemented with a digestible carbohydrate control

alpha-cyclodextrin which functions as a soluble dietary fiber, has been shown to a form a stable emulsion with dietary fat in the ratio of 1:9, with a higher affinity for saturated fat compared to unsaturated fat. in humans, supplementation with α-cyclodextrin has been shown to lead to a significant weight loss regardless of whether energy intake was maintained or increased.the aim of this study is to evaluate the results of a 72 hour fecal fat test using stool markers on the last three days of each of three six-day feeding periods. subjects will be served a weight maintaining diet containing 40% fat (of which 40% will be saturated), 30% protein and 30% carbohydrate for 18 days. subjects will also consume 1 gram alpha cyclodextrin with 1 gram of starch, 2 grams of alpha cyclodextrin, or 2 grams of starch in capsule form before breakfast, lunch, and dinner every day in each of the three six-day feeding periods. at this dose, alpha-cyclodextrin is recognized as safe by the fda. all stools will be collected over a 72 hour period at the end of each feeding period and analyzed for fecal fat excretion.

Eligibility criteria:
inclusion criteria: * bmi between 20 and 30 kg/m2 inclusive * weight ≥ 65 kg for females, and ≥ 55 kg for males exclusion criteria: * pregnant or nursing. * diabetes mellitus * any medication to reduce lipids * history of gastrointestinal surgery, except for cholecystectomy or appendectomy * history of malabsorption

Keywords: alpha-cyclodextrin dietary fiber fecal fat saturated fat
dpbrn development of a patient based provider intervention for early caries management

Conditions: Dental Caries

Summary: this study focused on improving the quality of dental care by fostering movement of the latest scientific advances into daily clinical practice.

phase 1 - development of two instruments (a patient brochure that described non-invasive caries treatment and a patient questionnaire of satisfaction with non-invasive caries treatment). phase 2 - field tested the patient brochure phase 3 - pilot tested the patient brochure, quantifying patient satisfaction with non-invasive caries treatments and a feasibility study that will inform the design of a clinical trial in dental practices envisioned for a later study.

Eligibility criteria:
inclusion criteria: * dentists enrolled in the dental practice-based research network (dpbrn) who participated in dpbrn assessment of caries diagnosis \& caries treatment and dbprn reasons for placing the first restoration on permanent tooth surfaces exclusion criteria: * patients under 19 years of age

Keywords: dental caries intervention non-invasive treatment for early caries